Ketogenic Diet Adjunctive to High Dose Methotrexate Chemotherapy for Primary Central Nervous System Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
Ketogenic diet has shown auxiliary effect on treatment of malignant tumors require high glucose consumption. This study is designed to evaluate the safety and efficacy of ketogenic diet adjunctive to high dose methotrexate(HD-MTX) chemotherapy for primary central nervous system lymphoma (PCNSL).
详细描述
In a pilot study of primary central nervous system(CNS) lymphoma patients, ketogenic diet was given in adjunction with standard HD-MTX chemotherapy as interventional group; standard HD-MTX is given with routine diet as control group. The primary endpoint is the safety of ketogenic diet in PCNSL patients receiving chemotherapy, secondary endpoints include rate of complete remission, remission time, rate of tumor relapse and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed PCNSL
- •No systemic involvement
- •Ability and willingness to sign informed consent
- •Normal liver and kidney function
- •Karnofsky Performance Score of 60 or more
排除标准
- •Any systemic involvement of the tumor
- •Systemic illness or medical condition may pose additional risk, including cardiac, metabolic or endocrine disorders; incompensated renal or liver disfunction; history of renal calculi, hyperuricemia, hyper calcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis
- •Uncontrolled hyperlipidemia or hyperglycemia
- •Human immunodeficiency virus positive, or hepatitis C positive
- •Pregnancy of breastfeeding
- •Inability or unwillingness to give written informed consent.
结局指标
主要结局
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
时间窗: Two years
The number and incidence (%) of treatment related adverse events among participants
次要结局
- The chemosensitivity of tumor(Two years)
- Long term effect of chemotherapy(Two years)
- overall survival(Three years)
- Quality of life(Two years)
研究者
Song Lin
Professor
Beijing Tiantan Hospital